Survey on Pre-ECT Evaluation and ECT Application

April 3, 2020 updated by: Klinički Bolnički Centar Zagreb

Multicenter Assessment of Pre-Electroconvulsive Therapy (ECT) Evaluation and ECT Application

The aim of this study is to identify specifics of pre-ECT assessments and ECT application in European psychiatric services. We will engage European centres that provide ECT for psychiatric patients and for psychiatric indications. It could bring better insights on current standards and possibly give some further improvements in the field of European ECT practices.

Study Overview

Status

Unknown

Conditions

Detailed Description

Electroconvulsive therapy (ECT) is an extremely important therapeutic method in the treatment of certain psychiatric conditions. Its' effect has been demonstrated in many clinical trials, and the indications for the use of ECT are clearly defined. Thus, the absolute indications for the use of ECT are catatonia and malignant neuroleptic syndrome, while the relative indications for ECT are therapy-resistant schizophrenia, depression and chronic suicidality. When the lead psychiatrist sets an indication for the use of ECT, pre-ECT evaluation is conducted. Although the pre-evaluation aims to assess the psychophysical condition of the patient and to determine the potential risks and possible side effects of such therapy, no clear algorithm of procedures is specified. There is no data on clear guidelines for the necessary processing prior to the application of ECT, both at national levels and globally. The assessment recommendations, however, are very broad, and most of them are focused on the ethical issues of applying ECT. The standardized pre-ECT evaluation would provide physicians and patients a systematic and evidence-based risk assessment and presumption of adverse reaction profiles.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
    • City Of Zagreb
      • Zagreb, City Of Zagreb, Croatia, 10000
        • Recruiting
        • Klinički bolnički centar Zagreb
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Departments that provide pre-ECT assessment, ECT application or both in Europe

Description

Inclusion Criteria:

  • departments that provide pre-ECT assessment
  • departments that provide ECT application
  • departments that provide both pre-ECT assessment and ECT application

Exclusion Criteria:

  • departments that used to provide either pre-ECT assessment or ECT application
  • departments that refer patients for ECT but don't provide pre-ECT assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pre-ECT evaluation data
Time Frame: Baseline

Data on pre-ECT evaluation collected with specially designed survey for this research.

Pre-ECT evaluation treatment includes are there written or agreed indications, inclusion and exclusion criteria and pre-ECT evaluation, the common neuropsychiatric and somatic evaluation for ECT candidate.
Baseline
ECT administration data
Time Frame: Baseline
Data on ECT application collected with specially designed survey for this research. The survey examines the most common methods of applying ECT, provided education and the necessary legal and ethical codes.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinički Bolnički Centar Zagreb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2020

Primary Completion (ANTICIPATED)

September 1, 2020

Study Completion (ANTICIPATED)

November 1, 2020

Study Registration Dates

First Submitted

April 3, 2020

First Submitted That Met QC Criteria

April 3, 2020

First Posted (ACTUAL)

April 7, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 7, 2020

Last Update Submitted That Met QC Criteria

April 3, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KBC Zagreb

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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